Diagnostic Value of 18F-Fluoride-PET/MRI in the Management of Suspected Facet Joint Arthropathy
NCT03317275 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2020-06-09
Summary
Prior to the injection, the facet joints have to be defined according to standard radiological techniques (e.g. MRI and physical correlation). Patients are then sent to 18F-Fluoride-PET/MRI imaging, in order to localize facet joints with increased uptake. Facet joints to be injected are again defined according to the location(s) of highest uptake as demonstrated by 18F-Fluoride-PET/MRI.
The defined injection sites before and after PET/MRI are compared. In equal defined injection sites, patients are sent for infiltration as scheduled, otherwise patients are randomized into two groups.
One group will undergo facet injection(s) according to the 18F-Fluoride-PET/MRI result, with standard injections performed under CT-guidance by the radiology department of the study site. The control group will undergo facet injections blinded to the 18F-Fluoride-PET/MRI results, but based on current standard clinical practise (MRI and clinical correlation).
The patients are asked to complete a validated pain and function questionnaire immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection, as performed routinely in our institution.
The purpose of this study is to prospectively evaluate the value of 18F-Fluoride-PET/MRI imaging in patients with low back pain with evidence of painful facet joint arthropathy, which would potentially benefit from facet joint injections.
Conditions
- Arthropathy of Lumbar Facet
- Pain, Back
Interventions
- DEVICE
-
18F-Fluoride-PET/MRI
facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques.
- PROCEDURE
-
facet injection
facet joint local anesthetic and corticosteroid injection according to the 18F-Fluoride-PET/MRI result or based on current standard clinical practise (MRI and clinical correlation) respectively
- OTHER
-
pain assessment by VAS
VAS questionnaire immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection, as performed routinely in our institution.
Sponsors & Collaborators
-
University of Zurich
collaborator OTHER -
Balgrist University Hospital
lead OTHER
Principal Investigators
-
Mazda Farshad, PD Dr. med. · Balgrist University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-26
- Primary Completion
- 2020-04-24
- Completion
- 2020-04-24
Countries
- Switzerland
Study Locations
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